Kornimate/medical-research-clean huggingface dataset:
the management of complicated colo-rectal cancer in older patients in the emergency setting: the co-older study

Conditions: Advanced Colorectal Cancer in Elderly Patient

Summary: this is a multicenter observational study aimed to investigate the management of older patients aged 75 years old and over admitted to the emergency department with complicated colorectal cancer. the final endpoint is to report morbidity and mortality in this group of frail individuals according to the shift of incidence of colorectal cancer in geriatric patients, over 2 periods: before the covid pandemic outbreak (11th march 2020) and after the 11th march, during the ongoing pandemic.


Eligibility criteria:
inclusion criteria: * patients aged 75 years old and over; * admission to the emergency department with acute abdominal pain; * diagnosis of obstructed and/or perforated colorectal cancer. exclusion criteria: * patients aged\< 75 years old; * patients aged \>=75 years old admitted with acute abdomen, not due to complicated colorectal cancer.

Keywords: elderly; oldest; colorectal cancer; perforation; bleeding; obstruction; emergency; surgery; laparotomy; laparoscopy; futility; frailty
prevalence of resistant hypertension with dot

Conditions: Hypertension

Summary: high blood pressure is a risk factor for bad clinical events, such as heart failure, stroke, kidney failure and death. this risk is much higher in those with 'resistant' hypertension, in whom the blood pressure remains high despite more than 3 blood pressure medicines. current estimates of the proportion of individuals with resistant hypertension may be an overestimate, since some of them are not actually adherent (i.e. not taking the medicines they are prescribed). methods to detect non-adherence, such as asking the patient, counting pills, and getting records from pharmacy are not fool proof. direct observed therapy (where patients are administered medicines under observation by a health care personnel) is quite useful to diagnose this, and is the standard of care in the renal hypertension clinic, before more tests and interventions (such as ct scans, renal angiogram) are performed. in this study, the investigators will measure the proportion of patients with resistant hypertension who are non-adherent based on direct observed therapy, and follow them up to examine the impact of this diagnosis.

this is a prospective, observational study. patients fitting inclusion and exclusion criteria, after informed consent, will undergo the direct observed therapy test in the hypertension unit (this is usual care in the unit, which they will undergo even if they are not part of the study). the direct observation therapy (dot) test includes the following components: 1. administer and observe ingestion of usual morning antihypertensive medications. 2. monitor bp every 30 minutes, using 5 readings of an automated oscillometric bp device ( bp-tru), until plateau affect achieved, defined as 3 consecutive cycles of bp readings declining by less than 10 mmhg per cycle). 3. registered nurse (rn) repeats standing bp prior to initiation of 24 hour ambulatory blood pressure monitoring(abpm). 4. rn initiates 24 hour abpm in addition, participants will undergo an additional 24-hour abpm test 1 month after the dot test is undertaken.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. confirmed resistant hypertension defined as daytime bp readings above 135/85 mmhg (confirmed by 24-hour abpm results) using 3 or more bp lowering drugs 3. adherence to medications confirmed by patient, and by hypertension clinic on basis of pharmacy filling record exclusion criteria: 1. pregnant patients 2. inability to provide informed consent

Keywords: hypertension adherence resistant hypertension blood pressure non-adherence
reducing the effects of aging on cognition with therapeutic intervention of an oral nutrient (reaction): a pilot trial

Conditions: Cognitive Decline

Summary: the purpose of this research is to assess the feasibility (e.g., recruitment rate, adherence rate and retention rate) of a clinical trial using virtual assessments to investigate the effect of a 6-month administration of a specific multi-nutrient oral supplement on cognitive aging. the study will also test whether a 6-month daily intake of a specific multinutrient can delay or reverse the effects of normal cognitive aging on other cognition domains as well as quality of life as measured by virtual assessments.

participants with cognitive aging who meet the eligibility criteria are provided study information and scheduled for a screening visit via virtual encounter. at the screening visit, participants meeting criteria are enrolled, and a baseline visit is scheduled (same day, or separately.) the participants are then randomized to either the test product (specific multi-nutrient) or placebo. study parameters will be assessed at baseline, and 6 months via a virtual online platform. patients will be contacted monthly via telephone to promote compliance and monitor progress. an optional sample of blood may be provided by the participant if willing to participated in this optional sub-study.

Eligibility criteria:
inclusion criteria: 1. english or spanish speaking participants considered to have age-related cognitive decline based on the following criteria: a) rbans (verbal memory retention) a score ≥70% on list learning retention and ≥80% on story memory retention and b) subjective cognitive decline (scd) 9-item brief screening tool score within the 25th percentile (scd =1) and 75th percentile (scd = 6) and c) moca ≥24 2. age 55-89 3. written informed consent provided by participant exclusion criteria: 1. enrollment in any other clinical trial within 30 days prior to participation 2. major neurocognitive disorder ("dementia") according to the diagnostic and statistical manual of mental disorders 5th edition and/or niaa criteria 3. use of any ad medication (e.g., cholinesterase inhibitors, nmda antagonists), or otc supplements or cognitive/memory enhancers 4. use of omega-3 fatty acids in the 30 days prior to participation 5. intake of vitamins b6 and b12, folate, vitamins c and e \> 300% rdi in the 24 days prior to participation 6. concurrent major medical or neurological illness 7. prior clinical history of stroke 8. history of substance abuse (e.g., alcohol, drugs) 9. untreated major depressive disorder that has not been in remission for at least 6 months prior to participation

Keywords: memory cognitive aging
a study of alirocumab in participants with autosomal dominant hypercholesterolemia (adh) and gain-of-function mutations (gofm) of the proprotein convertase subtilisin kexin 9 (pcsk9) gene or loss-of-function mutations (lofm) of the apolipoprotein (apo) b gene

Conditions: Hypercholesterolemia

Summary: the primary objective of the study is to assess the pharmacodynamic (pd) effect of alirocumab on serum low density lipoprotein cholesterol (ldl-c) during 14 weeks of subcutaneous (sc) administered alirocumab in patients with autosomal dominant hypercholesterolemia (adh) and gain-of-function mutation (gofm) in 1 or both alleles of the proprotein convertase subtilisin/kexin type 9 (pcsk9) gene or with loss-of-function mutation (lofm) in 1 or more alleles of the apolipoprotein (apob) gene.


Eligibility criteria:
inclusion criteria: inclusion criteria include, but are not limited to the following: 1. between the ages of 18 and 70 years, inclusive 2. a history of molecularly confirmed pcsk9 gofm for cohort 1 and a history of molecularly confirmed pcsk9 gofm or apob lofm 3. plasma ldl-cholesterol levels ≥70 mg/dl at the screening visit on a lipid-lowering therapy (llt) regimen stable for at least 28 days exclusion criteria: exclusion criteria include, but are not limited to the following: 1. serum triglycerides \>350 mg/dl at the screening visit 2. known to be positive for human immunodeficiency virus (hiv), hepatitis b virus, or hepatitis c virus 3. pregnant or breast-feeding women. 4. sexually active man or woman of childbearing potential who is unwilling to practice adequate contraception during the study
analgesic efficacy of dexmedetomidine added to fentanyl in pcea

Conditions: Abdominal Pain; Abdominal Cancer

Summary: dexmedetomidine if add to patient controlled epidural analgesia for patients undergoing major abdominal cancer surgery may improve its effects.

the aim of modern anaesthetic practice is to insure the rapid recovery of patients with fewer complications and earlier hospital discharge. thoracic epidural anesthesia (tea) has been established as a cornerstone in the perioperative care after thoracic and major abdominal surgery providing most effective analgesia. beyond its analgesic properties, tea's effects on the postoperative neurohumoural stress response, cardiovascular pathophysiology, and intestinal dysfunction have been in the focus of both clinical and experimental investigations for years. dexmedetomidine if add to patient controlled epidural analgesia for patients undergoing major abdominal cancer surgery may improve its effects.

Eligibility criteria:
inclusion criteria: * adult patients (21 years old or more), * classified as american society of anesthesiologists (asa) grade ii and iii, * scheduled for elective major abdominal cancer surgery. exclusion criteria: * patients with coagulopathy, * active neurological disease, * cutaneous disorders at the epidural insertion site, * allergy to the study medication * and patients refusal.
impact of hpv vaccine on the prevalence of hpv in norway

Conditions: Cervical Intraepithelial Neoplasia; Cervical Cancer; Oropharyngeal Cancer

Summary: the overall aim of the study is to assess the effect of school-based human papillomavirus (hpv) vaccination by comparing type-specific hpv prevalence between vaccinated and non-vaccinated women born in 1997. women born in 1997, residence to norway in 2009 (the year of vaccine initiation of the 1997-cohort) are invited to participate in the study.

this cohort is amongst the first that was offered hpv vaccine in an organized vaccination programme globally. the women will be recruited through facebook ads. the study will enable us to measure differences in the prevalence of hpv types in vagina and the mouth between vaccinated and non-vaccinated young women in norway. the womens vaccination status will be validated by linkage to the norwegian immunisation registry (sysvak) and their residence status will be validated through linkage to the norwegian population registry.

Eligibility criteria:
inclusion criteria: * female * born in 1997 * resident of norway in 2009 exclusion criteria: * male * born before or after 1997 * non-resident of norway in 2009

Keywords: hpv vaccines hpv-6 hpv-11 hpv-16 hpv-18 gardasil
a pilot methodology study to evaluate changes in bone quality parameters following therapy with forteo

Conditions: Osteoporosis

Summary: this methodology trial will be conducted in patients with osteoporosis and will measure the changes in bone quality parameters, micro- and macroarchitecture, bone biomarkers and bone density following therapy with the approved drug, forteo.


Eligibility criteria:
inclusion criteria: * postmenopausal women with osteoporosis exclusion criteria: * any therapies or products affecting bone turnover within 12 months of screening. * bisphosphonate treatment \>1 month in total duration at any time in the past. * in addition, patients must be bisphosphonate-treatment-free for at least 12 months prior to screening.

Keywords: 12 month therapy with postmenopausal women with osteoporosis to examine changes in bone quality parameters
non-interventional study with lyrica (pregabalin) in patients with epilepsy as adjunctive therapy of partial seizures to reduce seizure frequency

Conditions: Epilepsy

Summary: the primary efficacy parameter will be the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase


Eligibility criteria:
inclusion criteria: * age over 18 years old, patients with epilepsia with partial seizures * enrollment to study is fully on physician decision in compliance with current spc. exclusion criteria: * patient who did not meet indication according to spc lyrica
early mobilization after volar plate osteosynthesis of distal radius fractures

Conditions: Distal Radius Fracture

Summary: the aim of this study is to investigate the post operational mobilization after volar locking plate osteosynthesis of distal radius fractures. one group is admitted training exercises just after the fracture treatment, one group after 14 days immobilization in a cast. the primary hypothesis is, that immediate training leads to earlier and faster recovery. our second hypothesis is, that immediate training does not lead to increased risk of fracture displacement.

patients were followed for one year with controls after one, three, six and twelve months. occupational therapists blinded for the intervention examined the patients at all times. rom, strength and dash score was performed.

Eligibility criteria:
inclusion criteria: * over 50 years of age * distal radius fracture suitable for volar locking plate osteosynthesis * inhabitants in region sjaelland exclusion criteria: * dementia * abuse of drugs, medication or alcohol * open fractures * multitrauma or other injures on same extremity * earlier wrist fracture * delay of osteosynthesis of more than 14 days

Keywords: volar locking plate osteosynthesis early mobilization dash
incidence of acute kidney injury after laparoscopic cholecystectomy

Conditions: Acute Kidney Injury ,Laparoscopic Cholecystectomy

Summary: the aim of this study is to establish aki incidence in patients who are undergoing laparoscopic cholecystectomy and to identify the potential risk factors associated with the development of aki.

introduction: laparoscopic procedure produces adverse effects on splanchnic organs. pneumoperitoneum is a non-physiologic condition that causes a higher intra-abdominal pressure (iap) and is associated with significant direct and indirect effects on renal physiology. aim of the study: to establish aki incidence in patients who are undergoing laparoscopic cholecystectomy. to identify the potential risk factors associated with the development of aki. to establish the relationship between the iap during the procedure and the aki incidence. study design: study population: a single center prospective cohort study will be conducted. 100 patients undergoing elective laparoscopic cholecystectomy in the galilee medical center will be included. inclusion criteria: age \> 18 years, able to sign the consent form, stable kidney function. exclusion criteria: end stage renal disease, acute kidney injury or need of dialysis three months prior the procedure, acute infection, acute inflammation, bmi \> 40, malignancy and pregnancy. the diagnosis of aki will be made based on kidney disease improving global outcomes (kdigo) clinical practice guideline 2012, by comparing the baseline and post-operative serum creatinine and cystatin c and monitoring urine output during the procedure and after the procedure for 24 hours. data analysis: results will be presented as mean ± standard deviation for quantitative data. a p value of \<0.05 will be considered statistically significant.

Eligibility criteria:
inclusion criteria: * age \> 18 years, able to sign the consent form, stable kidney function. exclusion criteria: * end stage renal disease * acute kidney injury or need of dialysis three months prior the procedure * acute infection * acute inflammation * malignancy * pregnancy

Keywords: acute kidney injury , laparoscopic cholecystectomy
physiologically guided vt ablation

Conditions: Ventricular Tachycardia

Summary: the purpose of this study is to determine the efficacy of vt ablation guided by functional evaluation of the substrate to specifically target the reentry-vulnerable zones in patients with infarct-related vt.

activation mapping of vt is the gold-standard method for description of the reentrant circuit and identification of its isthmus, however this is uncommonly accomplished due to hemodynamic non-tolerance and limited temporal and spatial resolution. substrate mapping has been developed as an alternative method to identify the isthmus of post-infarction vt during sinus rhythm (sr). however, it has limited specificity to critical vt sites. fundamental work in animal models of healed infarction and humans has shown that the vt isthmus corresponds to locations characterized by marked activation slowing during sr. furthermore, these locations serve as "anchors" for multiple vt morphologies and cycle lengths. the hypothesis of this study is that activation mapping during sr or pacing can improve the specifically for identifying the critical vt sites. the aim of this prospective, multi-center controlled study is to evaluate the utility and limitations of functional mapping for guiding ablation of reentry vulnerably zones for long-term control of vt

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. history of myocardial infarction ≥1month before enrolment documented by ecg or cardiac imaging (tte, spect, cmr). 3. planned for first vt ablation procedure. 4. patients must have an icd or a plan for icd implantation after the ablation. 5. ability to understand the requirement of the study and to sign an informed consent. exclusion criteria: 1. patients requiring long-term treatment with class i or class iii antiarrhythmic drugs after ablation (for af). 2. the vt substrate is thought not to be related to coronary disease. 3. presence of ongoing ischemia that is thought to be the cause of the vt. 4. contraindication to anticoagulation therapy 5. stroke within 30 days before enrollment. 6. life expectancy \<1 year for any medical condition.
giessen pulmonary hypertension registry and biobank

Conditions: Pulmonary Hypertension

Summary: giessen pulmonary hypertension registry and biobank

long-term transplant-free survival and its determinants will be investigated in patients with pulmonary hypertension (diagnosed by right heart catheterization) within a prospective registry at a single referral center in giessen, germany.

Eligibility criteria:
inclusion criteria: * right heart catheterization for ph diagnosis in giessen exclusion criteria: * informed consent missing
post marketing surveillance for prosense™ a cryotherapy treatment of renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: this experiment is designed for post marketing data collection of a cryosurgical system \[prosense™ of icecure medical\], for the treatment of renal cell carcinoma (rcc).

a post marketing data collection of a cryosurgical system \[prosense™\] of icecure medical\], for the treatment of renal cell carcinoma (rcc).

Eligibility criteria:
inclusion criteria: 1. patient is above 18 years old. 2. the patient has enhanced solid mass of renal origin located in the kidney or elsewhere proved by imaging. 3. patient's mass size is up to 5 cm at its largest dimension. 4. patient is able to visit the clinic as needed during the 60-month follow-up period following the cryoablation procedure. 5. the patient has been informed of the study and agrees to its provisions, and has signed an irb approved written informed consent, including data privacy authorization. exclusion criteria: 1. patients with permanent coagulation disorders or severe medical instability or active infection. 2. patients with any terminal illness. 3. patient participating in other trials using drugs or devices.

Keywords: rcc renal cell carcinoma kidney tumors
post-marketing surveillance study of tolvaptan in patients with adpkd

Conditions: Polycystic Kidney, Autosomal Dominant

Summary: the purpose of this study is to evaluate the safety and effectiveness of tolvaptan in patients with autosomal dominant polycystic kidney disease (adpkd) in the real world clinical setting in japan.


Eligibility criteria:
inclusion criteria: * diagnosed adpkd * total kidney volume of 750 or more exclusion criteria: -
post-marketing surveillance (special use-results surveillance) on treatment with alhemo

Conditions: Haemophilia A, Haemophilia B

Summary: the purpose of the study is to investigate the safety and effectiveness of alhemo in participants under real-world clinical practice in japan. total duration of this study is about 6 years. participants enrolment will be completed in the first 4 years. the observation period of this study will last for about 2 years for each enrolled participant.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). * the decision to initiate treatment with commercially available alhemo has been made by the participant/legally acceptable representative (lar) and the treating physician before and independently from the decision to include the participant in this study. * male or female, age above or equal to 12 years at the time of signing informed consent. * diagnosis with haemophilia a (ha) or haemophilia b (hb). * participant who has never been exposed to concizumab or who starts treatment with concizumab within the past 12 weeks at registration. exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study. * treatment with any investigational drug within 30 days prior to baseline (the starting date of alhemo treatment). * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. * a history of hypersensitivity to any ingredients of alhemo.
promote awareness of the driving abilities of post-stroke patients.

Conditions: Cerebrovascular Accident

Summary: patients with cerebrovascular accident (cva) may present with a deficit of awareness of the disorders which results in a lack of correct self-estimation of their own abilities and difficulties in terms of both cognition and driving. it is therefore important to develop tools to help professionals take this deficit into account in their driving assessments and also to help patients better identify their real abilities. this research project thus proposes a protocol making it possible to promote decision-making whether or not to resume driving by multidisciplinary teams. the main objective is to determine to what extent video feedback promotes awareness of the ability to manage post-stroke patients, compared to a group of control patients receiving the usual recommendations.


Eligibility criteria:
inclusion criteria: * stroke (ischemic and / or hemorrhagic) between 1 month and 6 months * holder of a driving license for more than 3 years * no resumption of driving * moca score ≥ 10 * affiliation to a social security scheme or beneficiary of such a scheme * having signed a free, informed and written consent * medically stable exclusion criteria: * aphasia with severe comprehension disturbances, severe hemineglect, unstable epilepsy, severe visual disturbances (binocular vision \<6/10, visual field \<120 ° in binocular, \<50 ° to the right and to the left beyond the central point, \<30 ° vertically. * history of neurological disease responsible for cognitive impairment * need for vehicle modifications except automatic gearbox * subject being in a period of exclusion from another protocol * insufficient command of the french language * protected adults (curators) * pregnancy declared * being unable to issue their consent

Keywords: post-stroke